Cell Culture Dish – Ask the Expert Session

Our Next Session – Single-Use Technology for Microbial Fermentation

Microbial fermentation processes are used for biomanufacturing of various drugs and vaccines, such as hormones, antibody fragments, and pneumococcal vaccine. Stirred-tank fermentors up to 100,000 L scale have traditionally been used in such microbial processes and their success has formed the general engineering foundation and principles of the design of bioreactors. The majority of today’s fermentation processes are performed in bioreactors constructed of traditional materials such as stainless steel. However, there is an increased interest in disposable technology to gain flexibility, save batch change-over time, and minimize cleaning and cleaning validation efforts.

Headlines:

“GlaxoSmithKline (GSK.L) said on Thursday it is applying for regulatory approval for the world’s first vaccine against malaria, designed for children in Africa. The British drugmaker said the shot, called RTS,S, is intended exclusively for use outside the European Union but will be evaluated by the European Medicines Agency (EMA) in collaboration with the World Health Organisation (WHO).”

“Researchers from the University of California-San Francisco report a new stem cell discovery that might eventually lead to a more streamlined process for obtainingstem cells, which, in turn, could be used in the development of replacement tissue for failing body parts.”

“The National Institutes of Health is launching three new programs in emerging areas with the lofty goal of transforming biomedical research in the next 5 to 10 years. The initiatives, supported by the NIH’s Common Fund, include work on the effect of sugar modifications on proteins, the arrangement of DNA within cells in four dimensions, and the development of new therapies that allow control of organ function through manipulation of nerves.”

“A newly created startup called Emulate has picked up and plans to commercialize “Organs-on-Chips” developed at Harvard’s Wyss Institute for Biologically Inspired Engineering and intends to use them to speed up the development of pharmaceutical, chemical, cosmetic, and personalized medicine products, following an agreement made between the new private firm and Harvard’s Office of Technology Development.”

“Scientists are recognizing the power of transmogrifying cells to do their bidding. Heck, we recently found that heart cells can be reprogrammed into “pacemaker cells” through gene therapy. But it can still be a quandary to figure out an efficient way of inserting the necessary transformative materials into the cell.”

“U.S. regulators have accepted an application by Sandoz – the generics arm of Novartis – seeking approval for a copycat version of Amgen’s drug Neupogen, or filgrastim, for patients with low white blood cell counts. The Food and Drug Administration’s decision to accept the filing under a new pathway for so-called biosimilar drugs marks a milestone in the rollout of cheaper copies of injectable biotech medicines in the United States.

“AstraZeneca has signed up Roche and Qiagen to develop two separate diagnostic tests, both using simple blood samples, to identify patients who will benefit from its lung cancer drugs. Currently testing patients to see if their tumours contain genetic mutations that make them suitable for drug treatment involves collecting a sample of tissue by needle biopsy or during surgery.”